Today's blog is from Sathya Ganesan, Ph.D., RAC:

Lab Coat and Beyond

Sathya Ganesan, PhD, RAC

Regulatory Coordination Manager, Grifols Therapeutics Inc

 

When I entered graduate school at the University of Rochester in the mid 90s, learning the fundamentals of gene expression of steroid responsive genes was my objective. It was essentially basic research performing mutational analysis of estrogen receptor to understand how it affected the synergistic response to estrogen when multiple cis-acting EREs are present in a target gene.

Fast forward 10 years, after a Ph.D and a post-doc at Duke in a laboratory focused on using receptor molecular pharmacology to discover novel pharmaceutical agents to modify the biology in cancer cells, I landed a job as a scientist in a device start up. Needless to say getting hired to my first industry job was a breeze as I was familiar with the company's core technology, the founder was a friend and collaborator of my post-doc mentor, and they had sufficient funds to hire me.

Working in a small company funded by research grants was not any more different than working in academia for the most part. Things changed rapidly when the company focused on building its first product for FDA clearance to market.  All of a sudden we found ourselves in product development, design control and having to develop a Design History File. There was a new excitement to learn new things and a whole new way of doing things. Plan, write, review and sign off  what you intend to do, and document what you just did. If it wasn't documented, it did not occur. Words like 510k, predicate and substantial equivalence became part of our daily vocabulary.  That's when I realized I really enjoyed knowing about the product from a regulatory authority's stand point. It helps to understand what is expected of a company to get a product approved and strategize the development activities to ensure success to market.

I thank NCRAF for providing educational assistance through their RAC preparatory courses. The classes brought together scientific and regulatory professionals to learn, interact  and stay current on US regulations. I made several contacts through these classes, the group study sessions paid off and I earned US-RAC certification through RAPs.org. This was in November 2011. I also want to thank the Duke DTMI Regulatory Professionals for giving me an opportunity to work with them for several weeks practicing to write regulatory documents, and help network with other professionals trying to transition out of bench into regulatory.

Having a Ph.D, employed with several years of experience in the industry and a RAC certification wasn't sufficient to land a job in Regulatory, right away.  It took me two years to find the position I have today.

RTP NC is the ideal place to be if one is interested in clinical research/regulatory - with so many CROs in the area.  So, what was the trouble? My resume made it to the HR, but not beyond. My resume looked more like a scientific CV than a resume. I got help from several friends and professional contacts who took a look at my resume and helped format it differently - highlighting key accomplishments, re-wording my problem solving-skills to match the job description, to name a few edits. I needed additional skills to show that I can thrive in a changing environment and bring projects to completion and success. Susan Nichols of Women-in-Bio RTP, and Kay James of the Cystic Fibrosis Foundation were fantastic mentors at a time when I was lost in job search. They gave me clear objectives to fulfill for the two non-profit organizations. The activities I was engaged in enriched my resume, increased my network, and most of all boosted my confidence. 

I kept in touch with the many contacts I had in the various organizations in RTP (most of those in LinkedIn) who gave me their time, advice, introductions, and conversations about their own career experience that help me navigate my own. - and finally in May 2014, I got the call that led to my current job.

So for the many post docs and young scientists looking to get away from bench into regulatory -

  • trust in yourself,
  • build a strong resume
  • enrich your knowledge base - there is plenty of regulatory information out there
  • be active and contribute to an organization in the community that can help build your image and network
  • have a strong profile and presence in the social media
  • find a mentor and a mentor group where you can support one another
  • network, network, network

You will find that ideal job when you stop being desperate and projecting the confidence with all that you have already achieved in your bench career.